Day

December 30, 2009
Company:GE Medical Systems, LLC.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009 REASON GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that...
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Company:BioTek Instruments, Inc.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. Recall # Z-2223-2009 REASON Software design allowed false negatives to be read when wells are dark. RECALLING FIRM/MANUFACTURER...
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